Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire

• 2 recalls, same reason

  • Terminated Z-0177-2022 FDA Class II ·initiated 9 Aug 2021
  • Terminated Z-0178-2022 FDA Class II ·initiated 9 Aug 2021

  Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

510(k) Number

K792035 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Aire-Cuf Polyester Re-Enforced Endotracheal Tube

  Class II

  FDA 510(k) K872366 Active Cleared 17 Aug 1987

• Fome-Cuf Pvc

  Class II

  FDA 510(k) K780583 Active Cleared 12 May 1978

• Fome-Cuf and Aire Cuf Tracheostomy Tubes

  Class II

  FDA 510(k) K862267 Active Cleared 18 Jun 1986

• Bivona Nasal Turbinate Stent

  Class I

  FDA 510(k) K935053 Active Cleared 1 Jul 1994

• Bivona Carden Intermittent Jetting Device

  Class II

  FDA 510(k) K895946 Active Cleared 9 Jan 1990

• Bivona Fome-Cuf(R) Pediatric Tracheostomy Tube

  Class II

  FDA 510(k) K913270 Active Cleared 9 Aug 1991

See all devices from Bivona Medical Technologies →